Method and apparatus for coding diagnostic meters

ABSTRACT

A system for diagnostic testing may include a meter for performing a diagnostic test on a sample applied to a test media, the meter having a housing and an interface for receiving a signal representing coding information, and a container configured to contain test media compatible with the meter, the container having a coding element associated therewith. Additionally, the system may provide a mechanism for removing the meter from an interconnected test container and reattaching it to a new container using on-container coding methods that can recalibrate the meter for the new container of test strips.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. Ser. No.11/934,004, filed Nov. 1, 2007, which is a continuation-in-part of U.S.Ser. No. 11/373,284, filed Mar. 13, 2006, now U.S. Pat. No. 8,388,905,each of which is incorporated by reference in their entireties.

TECHNICAL FIELD

The present invention relates to the field of diagnostic testing and,more particularly, to diagnostic testing systems using electronicmeters.

BACKGROUND

Diagnostic testing systems are commonly used to perform various types ofdiagnostic tests on various types of samples. The diagnostic test may bea qualitative or quantitative test to determine the presence,concentration or amount of one or more analytes in a sample. The analytemay be a medically significant analyte—e.g., glucose, ketones,cholesterol, triglycerides, human choriogonadotropin (HCG), hemoglobinA1C, fructosamine, carbohydrates, tumor markers, lead, anti-epilepsydrugs, bilirubin, liver function markers, toxins or their metabolites,controlled substances, blood coagulation factors (PT, ATPP),etc.—contained in a biological sample—e.g., blood, urine, tissue,saliva, etc. But the diagnostic test is not limited to the medicalfield. In addition, diagnostic test meters can be used to monitoranalytes or chemical parameters in non-medical samples such as water,soil, sewage, sand, air, or any other suitable sample.

Such diagnostic testing systems may include a test media (e.g., a teststrip, tab, disc, etc.) configured to react to the presence of theanalyte in a sample, and a separate electronic meter configured tointerface with the test media in order to conduct the diagnostic testand indicate the results of the diagnostic test to the user.

In order to conduct the diagnostic test, a user must first obtain asample test media, e.g., a test strip, from a container, then obtain asample using a sampling device (e.g., by drawing blood using a lancet),and then apply the sample to the test media (either before or afterinserting the test media into the meter interface): The meter thenperforms the diagnostic test on the sample and indicates the result tothe user, e.g., using a numerical display.

Prior art diagnostic meters are sometimes bulky because the housingscontain the display, electronics, and test media. In addition, the userof a blood testing diagnostic system must manage and carry not only themeter, but also a test media container and a sampling device. Thesethree components must be manipulated in a certain order, which requiresa substantial amount of attention and manipulation to conduct asuccessful test. Not only are the steps cumbersome to some users, thereexists the possibility that the test media container, sampling device,and meter could be separated from each other, so that the user may findthemselves without one or more of the components necessary to conductthe diagnostic test.

As is known in the art, test media from different manufacturers or mediafrom different manufacturing lots may respond differently to thepresence or concentration of analyte in the sample. In order to obtainmore accurate results, the electronic meter may be calibrated withrespect to a given test strip from a brand or lot of test strips byproviding it with one or more brand- or lot-specific calibrationparameters that correlate the signal response from a particular brand orlot of test media to a standardized reference. By such calibration, theresults reported by the meter more accurately represent the amount ofanalyte in a sample.

Before running a diagnostic test, the meter needs to be properlycalibrated. The user may be required to provide the meter with theappropriate calibration parameters in a separate “coding” step. Forexample, the test media container may bear a code number which isentered into the meter, and from which the meter can access theappropriate calibration information stored in the meter's memory. Thecode number can be entered manually (e.g., using buttons or other userinput devices on the meter) so as to provide the calibration data to themeter. Alternatively, the calibration data may be downloaded, e.g., froma manufacturer's website. In another approach, the test media containermay be provided with an associated code chip, e.g. a ROM, in which thecalibration data is stored electronically. The user may provide thecalibration data to the meter by inserting the code chip into acorresponding port on the meter.

These prior art coding methods can be inconvenient or difficult for theuser. For example, elderly or infirm users may have difficultydownloading calibration data or inserting code chips, which must bephysically aligned properly in order to achieve a data connection withthe meter. Code chips can be misplaced or lost, leading to the inabilityto use corresponding test media, or using the test media with anunmatched coding device. Further, users may forget to calibrate themeter for use with a new brand or lot of test media. Consequently, theuser may enter incorrect calibration parameters or codes, or the usermay use test media from one brand or lot with a meter calibrated for usewith test media from a different brand or lot. Once a meter iscalibrated for a given lot of test media, the use of that meter withtest media from another lot may lead to erroneous results that couldhave serious consequences for the user. For instance, where the test isa self-test of blood glucose level, an erroneous result could lead theuser to act, or fail to act, in a manner detrimental to his or herhealth.

A possible solution to the above-mentioned coding problems is to insurethat all marketed media behave the same. This approach is referred to as“universal coding.” Universal coding schemes use strip lots that arecontrolled and sorted to a narrow acceptance criteria, i.e., all stripsare conformed to a single set of calibration parameters, thuseliminating the needs for multiple sets of parameters to be stored inthe meter. Universal coding saves the cost of replacing the meter byallowing it to be used with many different test strip containers. From amanufacturing perspective, universally coded media needs to be tightlycontrolled such that manufactured strip lots have the same behavior, andhence code, in order to fit the meter's fixed calibration data. Thismethod is not technique dependent and helps prevent errors due to mixedstrip lots. Furthermore, universal coding always has the correct codesuch that there is no miss-match between the meter and the strip lotcode. However, the narrow limits imposed by this method do not conformwell to large-scale manufacturing processes, which include inherentvariances. It is nearly impossible using high-throughput, batch-orientedmanufacturing techniques to ensure that test media will exhibitperfectly consistent behavior; thus, the universal coding schemeinvariably results in non-conforming lots of media. This media will beunusable, adding to cost and undesirable waste.

Accordingly, there is a need for diagnostic testing systems that areconvenient to carry and that minimize the chance that a user will use adiagnostic meter with test media from a brand or lot for which the meterhas not been calibrated.

A need also remains for removable meters than can be removed from onetest container and reused with a different test container.

SUMMARY

The illustrative embodiments described herein meet these and other needsby providing a diagnostic testing system including a meter forperforming a diagnostic test on a sample applied to a test media, themeter having a housing and an interface for receiving a signalrepresenting coding information, and a container configured to containtest media compatible with the meter, the container having a codingelement associated therewith, wherein transferring the meter from anassociated test container to a new container includes using one ofseveral coding methods that transfer lot specific code information fromthe new container of media to the meter.

Also provided herein further provide a meter housing with a receptaclethat can receive a test strip container. Additionally, the meter housingmay be configured to receive devices such as at least one of mediaplayers, terrestrial or satellite radios, travel alarm clocks, testalarms, memo voice recorders, PDAs, cell phones, or other add-onfunctionality, such that a code, similar to one placed on the test stripcontainer, can be read in order for the device to be used in conjunctionwith the meter.

Disclosed herein is a meter housing capable of being removed from afirst container and attached to a second container. The meter housingmay be configured with at least one top mount attachment configured toreleasably engage the meter housing and the container.

In an embodiment, the meter housing is configured to be removed byrotating the meter housing a sufficient distance to disengage the meterhousing from the container. For example, the meter housing may berotated at least about an ⅛ of a revolution, at least about an ¼ of arevolution, or at least about an ½ of a revolution.

In another embodiment, the container is configured to be removed byrotating the container a sufficient distance to disengage the containerfrom the meter housing. For example, the container may be rotated atleast about an ⅛ of a revolution, at least about an ¼ of a revolution,or at least about an ½ of a revolution.

In yet another embodiment, the top mount attachment is a hook capable ofreleasing the meter housing from the container. In another embodiment,the top mount attachment is a ring. In another embodiment, the meterhousing comprises a press fit post and the container comprises anorifice configured to receive the press fit post. In an embodiment, thetop mount attachment is a combination of a lock and a protrusion. In anembodiment, the top mount attachment is a tab.

Additional aspects and advantages of the invention will be set forth inpart in the description which follows, and in part will be obvious fromthe description, or may be learned by practice of the invention. Theadvantages of the invention will be realized and attained by means ofthe elements and combinations particularly pointed out in the appendedclaims.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate several embodiments of theinvention and together with the description, serve to explain theprinciples of the invention.

FIG. 1A is a perspective view of an integrated system consistent withthe embodiments disclosed herein.

FIG. 1B is another view of the integrated system depicted in FIG. 1 A.

FIG. 2A is a perspective view of an integrated system consistent withthe embodiments disclosed herein.

FIG. 2B is another view of the integrated system depicted in FIG. 2B.

FIG. 3A is a perspective view of an integrated system consistent withthe embodiments disclosed herein.

FIG. 3B is another view of the integrated system depicted in FIG. 3A.

FIG. 3C is another view of the integrated system depicted in FIG. 3A.

FIG. 4A is a perspective view of an integrated system consistent withthe embodiments disclosed herein.

FIG. 4B is another view of the integrated system depicted in FIG. 4A.

FIG. 4C is another view of the integrated system depicted in FIG. 4A.

FIG. 5A is a perspective view of an integrated system consistent withthe embodiments disclosed herein.

FIG. 5B is another view of the integrated system depicted in FIG. 5A.

FIG. 6A is a perspective view of an integrated system consistent withthe embodiments disclosed herein.

FIG. 6B is another view of the integrated system depicted in FIG. 6A.

FIG. 7A is a view of a embodiment of an integrated system including ameter housing capable of being released from a container by depressingan eject button.

FIG. 7B is another view of the integrated system depicted in FIG. 7B.

FIG. 7C is a view of the meter housing depicted in FIGS. 7A and 7B.

FIG. 8 is a perspective view of an embodiment of the system illustratinga meter having an interface for receiving a signal and a containerhaving a coding element.

FIG. 9 is a perspective view of an embodiment of an integrated systemconsistent with the embodiments disclosed herein.

DESCRIPTION OF THE EMBODIMENTS

Reference will now be made in detail to the exemplary embodiments of theinvention, examples of which are illustrated in the accompanyingdrawings. Wherever possible, the same reference numbers will be usedthroughout the drawings to refer to the same or like parts.

FIGS. 1A and 1B depict an integrated system 200 for conducting adiagnostic test in accordance with an exemplary embodiment of thepresent invention. Exemplary integrated system 200 includes a container210 for containing test media, such as test strips, and a meter 230 forperforming a diagnostic test using the test strips contained incontainer 210. The plurality of test strips may be contained in aninterior volume 213 of container 210. Such an interior volume may beopen, as shown in FIG. 9, permitting contact between test stripscontained therein.

Meter 230 may be contained within a meter housing 231. Meter housing 231is attached to or otherwise includes a top mount attachment 270 thatengages container 210 in order to selectively close an opening 211 ofthe container. As would be apparent to one of ordinary skill in the art,and as discussed herein, attached may be used to signify affiliatedwith, associated with, affixed with/to, connected with/to, coupledwith/to, fastened with/to, fixed with/to, secured with/to, etc.

In the embodiment depicted in FIGS. 1A and 1B, top mount attachment 270is a lock. Lock 270 extends from meter housing 231 and is configured toengage a corresponding protrusion 288 on container 210. Protrusion 288may be located along a portion of the upper lip of container 210.

In yet another embodiment, meter housing 231 comprises a tab 272positioned along the side wall of housing 231. Tab 272 extends beyondthe side wall to facilitate the user in removing housing 231 fromcontainer 210, for example, by pushing upward, for example, with afinger or thumb against tab 272.

In one embodiment, tab 272 comprises one or more ridges to aid the userin applying force to tab 272. The ridges may function to prevent theuser's finger or thumb from slipping from tab 272.

In another embodiment, tab 272 may extend at an angle away from the sidewall of housing 231. When measured relative to a vertical plane parallelto the side wall of housing 231, the angle of tab 272 ranges from about1 degrees to about 90 degrees, from about 20 degrees to about 70degrees, or from about 40 degrees to about 50 degrees. The angle maymeasure about 45 degrees.

Although FIGS. 2A and 2B depict a single protrusion, the skilled artisanreadily understands that the top mount attachment may comprise more thanone tab. For example, two tabs may be spaced apart up to about 180degrees from one another, and the user may hold container 210 pushupward on each tab while anchoring the container, for example, in thepalms of both hands or on a surface.

FIGS. 3A, 3B, and 3C depict yet another top mount attachment forreleasably attaching meter housing 231 to container 210. In thisembodiment, meter housing 231 comprises at least one lever 274 and atleast one hook 290 interconnected so that applying a force to at leastone lever 274 moves at least one hook 290. Lever 274 comprises aflexible material and/or flexible configuration. Container 210 comprisesat least one detent 276 capable of receiving hook 290. A user removeshousing 231 by squeezing lever 274 towards housing 231. Squeezing lever274 in the direction towards housing 231 releases hook 290 from detent276. Housing 231 may then be removed from the top end of container 210.

FIGS. 3A-3C depict one lever, one hook, and one detent configured towork together as a single closure mechanism. The skilled artisan readilyunderstands that more than one combination of lever, hook, and detentmay be used. In an exemplary embodiment, the top mount attachmentcomprises two levers, two hooks, and two corresponding detents.

In a further embodiment, the meter housing comprises a mechanism, forexample, a button, configured to actuate the at least one hook. FIGS.4A, 4B, and 4C comprise yet another configuration for top mountattachment comprising at least one lever 274, at least one detent 276,and a button 278. Button 278 and at least one detent 276 areinterconnected so that pressing button 278 engages detent 276. Whendetent 276 is positioned within a recessed area (not shown) of container210, pressing button 278 releases detent 276 from the recessed area. Toattach housing 231 to container 210, a user may position housing 231adjacent to container 210 so that detent 276 and the recessed area arealigned. Pressing button 278 allows detent 276 to engage the recessedarea.

In a further embodiment, button 278 is configured to disengage detent276 from meter housing 231. In this embodiment, the step of pressingbutton 278 allows the meter housing 231 to be removed from container210. To reattach meter housing 231 to container 210 or to a secondcontainer, the user may snap meter housing 231 onto container 210 or asecond container.

Button 278 may be comfortably pressed with the right thumb or indexfinger while the integrated system 200 is held in the right hand. Butbutton 278 may be positioned elsewhere on meter housing 231. Forexample, button 278 may be placed on a right hand side of meter housing231 in order to be more convenient for left handed users or on a topportion of the meter 230.

FIGS. 5A and 5B depict a top mount attachment comprising a press fitpost 282. Container 231 comprises press fit post 282 and container 210comprises an orifice 284 sized to receive press fit post 282. Press fitpost 282 fits within orifice 284, thereby sealing orifice 284 againstthe infiltration of light, liquid, and vapor. In an embodiment depictedin FIG. 5B, press fit post 282 comprises partial post 282′ and partialpost 282″. Partial post 282′ and partial post 282″ are spaced apartcreating a hollow strip.

In yet another embodiment, a connector attaches container 210 to housing231. The connector may be releasably attached to container 210 and/orhousing 231. In the embodiment depicted in FIGS. 6A and 6B, theconnector comprises a snap-on adaptor ring 286. Snap-on adaptor ring 286is sized to accommodate the cross-sectional shape of container 210.Snap-on adaptor ring 286 may be configured to loosely and frictionallyengage container 210.

In another embodiment, the connector is a screw-on adaptor ring thatreleasably screws onto container 210. Inter-engaging threads on theinner surface of ring 286 engage threads on the outer surface ofcontainer 210. Threads may also engage threads on meter housing 231.

In another embodiment, the connector may be affixed to container 210 orhousing 231 by, for example, welding, gluing, and the like. Forinstance, if the connector is permanently or semi-permanently affixed tocontainer 210, then housing 231 may be releasably attached to theconnector. For example, the releasable feature of connector 210 may be aquarter turn, snap fit, or thread. In another example, the connector maybe permanently or semi-permanently affixed to meter housing 231 andreleasably attached to container 210.

The shape of ring 286 may take a shape consistent with thecross-sectional shape of container 210 and meter housing 231. In oneembodiment, the shape of ring 286 is a circle. In another embodiment,the shape of ring 286 is oval. In yet another embodiment, the shape ofring 286 is elliptical. In another embodiment, the shape of ring 286 isrectangular.

In yet another embodiment, the connector is sized to connect a containerof a first cross-sectional shape and a meter housing of a secondcross-sectional shape.

FIGS. 7A-7C depict an embodiment wherein housing 231 includes an ejectbutton 292. Eject button 292 is configured, when depressed, to releasehousing 231 from container 210.

In FIGS. 7A-7C, eject button 292 is depicted as located on the upperportion of housing 231, yet the skilled artisan understands that ejectbutton 292 may be located at any suitable position along housing 231.

FIG. 8 is a perspective view of an embodiment of the system illustratinga meter having an interface for receiving a signal 255 and a containerhaving a coding element 249. When removable meter 230 is attached tocontainer 210, interface 255 makes contact with coding element 249 toreceive a signal representing coding information.

In an exemplary embodiment, container 210 and closure 240 are formed ofpolypropylene using an injection molding process. However, othermaterials and processes may be used without departing from the scope ofthe present invention.

Other embodiments will be apparent to those skilled in the art fromconsideration of the specification and practice of the embodimentsdisclosed herein. It is intended that the specification and examples beconsidered as exemplary only.

What is claimed is:
 1. A system for diagnostic testing comprising: ameter housing configured to house an electronic meter for performing adiagnostic test on a sample applied to a test medium, the meter housinghaving a test port; a plurality of test medium compatible with theelectronic meter, each test medium of the plurality of test mediumhaving a first end and a second end, the first end having a width and aheight, wherein a width and a height of the test port is approximatelyequal to the width and the height of the first end for insertion of thefirst end into the test port; and a container having an open interiorvolume permitting contact between the plurality of test medium housedtherein; and at least one lock protruding from the meter housing and atleast one corresponding protrusion protruding from at least a portion ofa lip of the container, the at least one lock configured to slidablytraverse at least a portion of the at least one protrusion, wherein in afirst position, the at least one lock and the at least one protrusionare disengaged so that the meter housing is capable of being removedfrom a top end of the container, and wherein in a second position, theat least one lock and the at least one protrusion are engaged so thatthe meter housing is prevented from being removed from the top end ofthe container.
 2. The system according to claim 1, wherein the housingcomprises at least one tab extending from a side wall of the housing,wherein the tab has a top surface.
 3. The system according to claim 2,wherein the top surface of each tab comprises one or more ridges.
 4. Thesystem according to claim 2, wherein the tab extends at an angle fromthe side wall, wherein the angle, relative to a vertical planesubstantially parallel to the side wall, ranges from about 1 degree toabout 90 degrees.
 5. The system according to claim 1 further comprisingat least one lever integrally molded with the housing, each lever beinginterconnected to a hook, and the container comprises at least onedetent configured to receive the hook.
 6. The system according to claim1, wherein the meter housing comprises a button interconnected to a hookand a lever, and the container comprises a detent, wherein pushing thebutton concomitantly disengages the hook from the detent.
 7. The systemaccording to claim 1, wherein the meter housing comprises a press fitpost and the container comprising an orifice sized to receive the pressfit post.
 8. The system according to claim 7, wherein the press fit postcomprises a first partial post and a second partial post, wherein thefirst partial post and the second partial post are spaced apart.
 9. Thesystem according to claim 1, wherein the housing comprises an ejectbutton configured to release the housing from the container.
 10. Asystem for diagnostic testing comprising: a meter housing configured tohouse an electronic meter for performing a diagnostic test on a sampleapplied to a test medium, the meter housing having a test port; aplurality of test medium compatible with the electronic meter, each testmedium of the plurality of test medium having a first end and a secondend, the first end having a width and a height, wherein a width and aheight of the test port is approximately equal to the width and theheight of the first end for insertion of the first end into the testport; and a container including a top end and configured to contain testmedium compatible with the electronic meter; multiple locks protrudingfrom the meter housing and multiple corresponding protrusions protrudingfrom at least a portion of a lip of the container, each lock configuredto slidably traverse at least a portion of each protrusion when themeter housing and the container are rotated with respect to one another;wherein in a first rotation position, each lock and each protrusion aredisengaged so that the meter housing is capable of being removed fromthe top end of the container; and wherein in a second rotation position,each lock and each protrusion are engaged so that the meter housing isprevented from being removed from the top end of the container.
 11. Thesystem according to claim 1, wherein the test port is positioned on anouter surface of the housing.
 12. The system of claim 11, wherein, whena test medium of the plurality of test medium is inserted into the testport, the first end of the test medium extends into the test port andthe second end of the test medium extends away from the test port andelectronic meter.
 13. The system according to claim 10, wherein the testport is positioned on an outer surface of the housing.
 14. The system ofclaim 13, wherein, when a test medium of the plurality of test medium isinserted into the port, the first end of the test medium extends intothe test port and the second end of the test medium extends away fromthe test port and electronic meter.